The following data is part of a premarket notification filed by Taidoc Technology Corporation with the FDA for Nexus Ir30 Non-contact Infrared Forehead Thermometer.
| Device ID | K122221 |
| 510k Number | K122221 |
| Device Name: | NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | TaiDoc Technology Corporation 3F,5F, No.127, Wugong 2nd Rd. Wugu District New Taipei City, TW 24888 |
| Contact | Pinjung Chen |
| Correspondent | Pinjung Chen TaiDoc Technology Corporation 3F,5F, No.127, Wugong 2nd Rd. Wugu District New Taipei City, TW 24888 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-25 |
| Decision Date | 2013-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884389182393 | K122221 | 000 |
| 00888277707958 | K122221 | 000 |
| 40888277183996 | K122221 | 000 |